| Assessment Status | Rapid Review Complete |
| HTA ID | 26025 |
| Drug | Onasemnogene abeparvovec intrathecal |
| Brand | Itvisma® |
| Indication | Onasemnogene abeparvovec intrathecal is indicated for the treatment of 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene in patients 2 years and older. |
| Assessment Process | |
| Rapid review commissioned | 28/05/2026 |
| Rapid review completed | 16/07/2026 |
| Rapid review outcome | A full HTA is not recommended. The NCPE recommends that onasemnogene abeparvovec intrathecal not be considered for reimbursement at the submitted price*. |
The NCPE Rapid Review of onasemnogene abeparvovec intrathecal (Itvisma®) is the first national assessment to be completed for a drug with an EU Joint Clinical Assessment (JCA). The JCA Report was endorsed on 16 July 2026. The published report will be available here Joint Clinical Assessments – Public Health – European Commission pending an assessment of requests from the Applicant on data considered by them to be commercially confidential.
Next steps: The NCPE Assessment Report and recommendation, and the JCA report will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.
Further information on this process may be found here
Further information on the status of this decision may be found here